PMA P150012S080
- Device
- Essentio, Proponent, and Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S080
- Product code
- LWP
- Decision date
- 2019-09-18
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families.
Current openFDA PMA Record#
- Device
- Essentio, Proponent, and Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S080
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-09-18
- Decision code
- APPR
- Date received
- 2019-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families.